MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number 106531INT

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that on the first post operative night the system controller started to alarm.The controller screen did not show any pump parameters but alarmed with a communication fault.The heartmate monitor did not show pump parameters either.Green pump symbol on the system controller was okay and the patient was stable.The system controller was exchanged and the problem resolved.There were no new alarms after that.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the controller not showing any parameters and alarming with a communication fault was confirmed via visual analysis and testing of the controller and via analysis of the downloaded log file.The heartmate 3 system controller (serial number (b)(6) ) was returned and evaluated at abbott.During the evaluation, the controller was connected to a mock circulatory loop and a log file was downloaded.The downloaded log file from the returned system controller contained data spanning approximately 1 day (04jul2022 ¿ 05jul2022 per the timestamps).The log file captured intermittent controller internal fault alarms active throughout the log file due to a timebase fault.The alarm would resolve intermittently and then reoccur intermittently.The alarms did not resolve by the end of the log file.While the timebase faults were active, it appears as if the fixed and low speed limits were changed as there was a loss of lvad communication.The flow also appeared to drop as a result of the loss of communication.Additionally, the controller was functionally tested and passed all steps without issue; however, while the controller was operating on a mock circulatory loop for an extended period of time, the controller had a communication fault active.While the communication fault was active, the controller was not communicating with the system monitor, confirming the reported event.Circuit analysis revealed that the communication fault and communication issue with the system monitor was intermittent.The circuit analysis of the controller¿s circuitry did not reveal any issues with the components, and it appeared that the circuit was continuously resetting the microcontroller.A possible issue with the microcontroller was suspected and the pcb was forwarded to the vendor (plexus manufacturing) for further evaluation along with another pcb which was demonstrating similar behavior.A manufacturing task was initiated to investigate further.The root cause of the hm3 controller issue is due to the microprocessor corrosion issue on the control main pcba, but it is inconclusive how the control main pcba had an issue post-manufacturing and testing at abbott mcs.An external corrective action report (ecar) was created to address the issue.The manufacturer was notified of the complaint through the ecar, and the supplier will address this issue and provide a response with the corrective action.The root cause of the reported event was determined to be due corrosion within the microcontroller; however, the root cause of the corrosion could not be conclusively determined through this analysis.The device history records were reviewed, and the records revealed the heartmate 3 system controller (serial # (b)(6) ) was manufactured in accordance with manufacturing and quality assurance specifications.The system controller (serial # (b)(6) ) was shipped from abbott on 04jan2022.Heartmate 3 patient handbook section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the controller fault alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 patient handbook section 6, entitled "caring for the equipment", describes how to care for and clean all equipment, including the system controller.Heartmate 3 patient handbook cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15004891
• MDR Text Key: 301579813
• Report Number: 2916596-2022-12178
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531INT
• Device Lot Number: 8286368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1